Abstract

AimTo determine the effect on glycaemic control over three years, by selecting patients living with diabetes or diabetes and hypertension from a crowded chronic disease clinic (CDC) in a public health centre and treating them in a special diabetic clinic (DiaC) using resources available at the health centre. MethodsAn uncontrolled observational cohort study. One hundred and one patients from the CDC volunteered to join the DiaC and were followed for three years in the DiaC. Patients in the DiaC were provided with greater consultation times, more frequent clinic appointments and more frequent lifestyle advice than patients in the CDC. HbA1c levels were done at the start of the project (0 months) and at three, 24 and 36 months after the start. The DiaC was run by a primary care physician (PCP) and registered nurse (RN). Results Eighty-six patients completed follow-up. The mean HbA1c +/– standard deviation scores at 0, 3, 24 and 36 months were: 9.44+/–1.27%, 9.50+/– 2.22%, 8.33+/–1.97% and 7.96+/–1.84% respectively (P0.0005 for difference between 0 and 36 months). ConclusionA special diabetic clinic run by a PCP and an RN in a primary care setting where regular monitoring of glycaemic control is done, where patients concerns and fears about diabetes are addressed, where patients are educated about diabetes, diet and exercise and advised on compliance with medication leads to improved glycaemic control after three years. This low-cost clinic could be readily established in other developing countries.

Keywords

Caribbean, diabetes, intervention, patient-centred care, primary care

Introduction

Strict glycaemic
control in patients living with dia-betes (PLWD) can lead to a reduction of
long-term complications,[1,2] therefore optimal control in each
patient afflicted with diabetes is desirable. Despite frequent monitoring
of glycaemia[3] and new drugs being introduced, diabetic control in
patients from both developed[4] and developing countries[5,6] remains sub-optimal.

Trinidad and Tobago is a developing nation with an estimated prevalence
of diabetes of about 20%.[7] The economic impact of diabetes in
Trinidad and Tobago is exorbitant.[8] Cross-sectional studies looking
at PLWD attending public health centres in Trinidad and Tobago show that
glycaemic control is generally poor.[5,9]

Most PLWD in Trinidad and Tobago receive treat-ment at public health
centres where they are treated primarily by general practitioners (GPs) or less
fre-quently by doctors with postgraduate qualifications in primary care and
family medicine (PCPs). The re-mainder are treated by private GPs, with a
minority of patients being treated by internal medicine specialists or
diabetologists. There is no group approach to the care of patients
afflicted with diabetes, so the doctor does most of the counselling and
medication adjust-ments.

At present there are one to two clinic sessions per week per public
clinic dedicated to chronic diseases (CDC) where patients affected with
diabetes are seen together with other patients suffering from:
hyperten-sion, ischaemic heart disease, cerebrovascular acci-dents, epilepsy
and thyroid disorders. Owing to large clinic sizes and the few doctors attached
to these clinics, doctor–patient consultations last about five minutes per
patient. Patients are seen every four to six months at these clinics. This is
insufficient to explore patients’ fears and concerns about diabetes and is
inadequate to counsel patients about lifestyle changes and compliance that
could benefit them.

Evidence emerging suggests that PLWD who are enlightened about their
condition are more likely to have better glycaemic control than those patients
who are not. In addition patients whose concerns and fears of diabetes are
addressed by the attending medical staff

The aim of this study was to determine the effect on HbA1c levels
for patients living either with diabetes alone or with diabetes and
hypertension who were transferred from the CDC to a separate diabetic clinic
(DiaC), within the same public health centre, a setting providing longer
consultation times, more frequent monitoring of glycaemia, investigations into
concerns and fears of patients and annual counselling on exer-cise and diet.

Methods

All 960 CDC
patient notes were hand searched by the researcher to identify patients
suffering with diabetes alone or with diabetes and hypertension. The
inclusion criteria were: any sex, no recorded gross micro- or macrovascular
complication of diabetes, insulin or non-insulin dependent diabetes. To
determine the absence of gross complications of diabetes in the participants,
patients with the following were excluded: proteinuria, symptoms of angina and
peripheral vas-cular disease and any recorded diagnosis of diabetic retinopathy
and a creatinine level of more than 106 mmol/L. Each participant was
interviewed to determine his/her willingness to join the DiaC. This clinic was
held separately from the CDC. One hundred and twenty-five patients met the
inclusion criteria and were invited to participate. One hundred and one
patients accepted the invitation to participate. This study was done in
accordance with the criteria of the Declaration of Helsinki (1964). All 101
patients gave written informed consent that they would participate in the study
and for the use of their results in this manuscript. This project was a Quality
Improvement Project and approval to carry out this project was obtained from
the Quality Department of the South West Regional Health Authority, under whose
jurisdic-tion the project fell. The project started in November 2003.

An HbA1c level of </=7.0%
was considered good glycaemic control.

Intervention

Patients were
given clinic appointments every three months. Those patients who needed closer
monitor-ing were scheduled more frequently. The average doctor–patient or
nurse–patient consultation lasted 10–12 minutes. The total time taken for the
clinic was divided by the number of patients seen, leading to the average time
per patient. The number of consultation times per year for each patient in the
DiaC was recorded. The patients were informed that the desired HbA1c level was
7% or lower. About ten patients per session were booked. There were no fixed
formats to consultations but patients’ cues were used to start discussions.
Once a year each patient received advice from the PCP about exercise and was
subjected to an individualised dietary counselling session with a diet-ary
technician.

Glycosylated haemoglobin (HbA1c), lipid profile and renal function were
tested annually. Weight and blood pressure were measured at each visit. There
was a problem with
the supply of reagents at the laboratory for the HbA1c so the tests to be done
at 12 months were not completed.

Patients’ fears and concerns were addressed at all sessions and
compliance with medications and medi-cal advice reinforced. Patient education
about dia-betes was covered individually at each clinical session.

The same PCP and researcher conducted about 90% of the clinic sessions.
Locum staff did the other 10%. The doctor was a PCP and the nurse was a
trained registered nurse (RN). Both had an interest, but no specialised
training or qualifications, in diabetes care and management. Both were employed
full time in the public health centre and used a free afternoon session to hold
this special clinic.

The mean baseline HbA1c level in this cohort was compared with the mean
HbA1c levels at three, 24 and 36 months. This was done using the paired sample t
test between the baseline HbA1c and each of the means of the three subsequent
HbA1c levels taken. SPSS Version 10 (Chicago, USA) was used to analyse the
data.

Results

One hundred and
one patients started the project and 86 patients could be accounted for three
years later. Four patients died (one from an accident during the first year and
three from myocardial infarctions dur-ing the second and third years of the
study), four migrated (two each during the first and third years), five were
re-registered at the original CDC and two could not be accounted for. Males
accounted for 28.7% and females for 71.3% of the studied popu-lation. The
average age of patients at the start of the project was: 52.5+/–8.2 years
(range: 31–68 years). The median length of time between the patients being
diagnosed with diabetes and enrolling in the DiaC was five years (range: three
months to 11 years).

Patients in the DiaC were seen a mean of 4.2 times per year and those
in the CDC were seen a mean of three times per year (based on an
appointment every four months).

Table 1 shows the difference in mean HbA1c be-tween baseline and
each of the three other HbA1c values.

Overall the proportion of patients having good glycaemic control over
the three years of the study had increased. Five out of 101(5.0%) had HbA1c
levels of less than 7% just before the start of the project, whereas 29 out of
86 (33.7%) had HbA1c levels of less than 7% at 36 months after the start.

Discussion

This study shows
that the introduction of a DiaC for uncomplicated patients suffering from
diabetes and diabetes with hypertension within a primary care setting led to
significant improvements in glycaemic control over three years. This
improvement was not apparent within the first three months of the study, which
suggest that this intervention is geared to inter-mediate term control of these
diabetic patients. By taking these patients out of a crowded CDC and pro-viding
them with consistently longer doctor–patient and nurse–patient consultation
times where their con-cerns and fears are addressed and explored, together with
the annual exercise and dietary advice provided, leads to improved glycaemic
control over a three-year period. Importantly, this was a complex intervention
and an analysis of each individual component’s con-tribution to the overall
success was not made.

The glycaemic control of
patients just before the start of this clinic was poor, and this supports the
work done previously in Trinidad.[5,9] A medical consul-tation lasting
about five minutes for a patient suffering with diabetes does not give
enough time to explore fears and concerns about their disease. Studies that
show significant improvements in glycaemic control over time have included
interventions where patients’ fears and concerns about diabetes were addressed
and

where patients were educated about diabetes
so as to take control of their condition.[10,11]

Having smaller clinics with all patients having the same diagnosis
leads to greater patient interactions and becomes an informal support group for
these patients where fears about their condition are analysed. It was observed
that most patients with poor readings felt badly about this and were motivated
to do better, especially if other persons in their clinic session had good
results.

Trento et al showed that structured group visits of PLWD improved
glycaemic control as opposed to PLWD who received individual consultations
after a two-year follow up. Those in the structured group also had improved
quality of life, improved knowledge of diabetes and exhibited more appropriate
health behav-iours than those seen individually. More importantly, seeing a
group comprising of nine or ten patients took less time than seeing the same
number of patients individually.[12] Such an approach could well be a
cost-effective method of dealing with overcrowded CDCs, as occur in
Trinidad and Tobago and other developing countries.

It is notable that this clinic was run by a PCP and RN both of whom had
no postgraduate qualifications in diabetes. De Berardis et al found that being
followed by the same physician in a diabetic outpatient clinic, especially if
the physician had a speciality in diabetes, led to improved process outcomes
such as more frequent testing of lipids and HbA1c levels.[13] Aubert et
al show that having a nurse case manager following written algorithms working
together with a primary care physician and endocrinologist led to improved
glycaemic control in patients suffering with diabetes.[14] This
present study shows that having the same phys-ician and nurse working together
over a prolonged period of time with a cohort of patients led to a similar
improved process and improved glycaemic control, though neither had any
postgraduate qualification in diabetes. Based on the results obtained, there is
some significance of having the same health providers fol-lowing up these PLWD
on a long-term basis.

A small study showed that having community pharmacists discuss
medications, clinical goals and self-care activities with patients
suffering from diabetes did lead to an increased compliance with
diabetes-related lifestyle activities such as diet and exercise, though clinical
outcomes did not improve.[15] This role of the community pharmacist
could be a further adjunct to the team approach to management of PLWD in
developing countries

There was an average decrease in HbA1c of almost 1.5% over the three
years. While impressive, it should be remembered that the initial glycaemic
control of this cohort was poor. Studies which show the greatest

improvements in
HbA1c levels are those having the highest HbA1c levels at the start of their
projects.[11,16]

A systematic
review showed that there is some benefit of individual patient education as
opposed to usual care on
glycaemic control in patients whose baseline HbA1c levels were greater than 8%
when followed for 12–18 months.[17] In the present study, most
patients had HbA1c levels of more than 8% at the start, and this may have
contributed to the success in terms of a significant reduction in the HbA1c
levels at three years into the project compared with the start.

An important consideration for healthcare man-agers is that this
quality improvement project was implemented without any additional burden on
the health budget. No additional staff were recruited for this project.
The same dietitian that was used for the CDC was used for the DiaC. Staff
simply adjusted their daily schedules to facilitate this added clinic.
Medi-cations were initially obtained from the clinic phar-macy and, with the implementation
of the CDAP program, patients also benefited from this additional source of
medications.

The limitations of this study should be noted. The major limitation of
this study is that it was an un-controlled observational cohort study where
patients volunteered to participate. This could have led to the potential for
selection bias with more motivated patients volunteering to join the DiaC. The
results therefore cannot be extrapolated to all diabetic patients but only to
the compliant ones. Three years of follow-up could show trends in improving
glycaemic control, but is insufficient to predict the long-term benefits
of the clinic. A five to ten-year follow-up is more suitable to determine the
effectiveness of any study involving chronic diseases. The missing 12
month data would have been important to give a better impression of how long it
took to get significant improvements in glycaemic control. This study suggests
that this occurred at between three and 24 months.

This project changed the
authors’ practice in pri-mary care diabetes as now smaller clinics are booked
with more frequent follow-up visits for those who exhibit poor glycaemic
control. Consultation times have increased to about eight minutes per patient.

In conclusion, a special
diabetic clinic established in a public primary care clinic run by a PCP and
RN, where patient education about diabetes is ongoing and patient centeredness
is apparent, leads to improved glycaemic control in patients over the
intermediate term, but not the short term. This is a model that is simple to
adopt and requires a simple service redesign of existing clinic sessions. It
may be of benefit in many primary care settings, especially in developing
countries.

Acknowledgements

This study was
carried out as a Process Improvement Project for the Quality Department of the
South West Regional Health Authority (SWRHA). The final report was presented to
the Quality Department in a quality format and a summary of the findings was
presented at the ‘Caribbean
Chronic Care Collaborative: Improv-ing the Quality of Diabetes Care’
International Learn-ing Session 1 in Grenada on the 18th and 19th of December
2008.

Special thanks to the Quality Improvement Group at Princes Town
District Health Facility for the project entitled: ‘Improving Glycaemic Control
in Diabetic Patients at Princes Town District Health Facility’. They are: Arit
Charles, Waheeda Rahim, Wendy Thomas, Dolores Sookoo, Brenda Bonas, Vedatee
Bridgemohan, Dr Kumar Ramgoolam, Patsy Chankersingh, the Quality Department at
the South West Regional Health Authority, Michael Harris and Terrence Honore.

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